510(k) · Cleared
ClearedMas and Mini-Trol PTH Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Dec 3, 2009 as substantially equivalent to K043108 (Bio-Rad Laboratories, Inc., 2004) after an 86-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Dec 3, 2009
- Review
- 86 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K891475 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK891475 Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Bio-Rad · 1989
- 2 generations backK981532 Lyphochek Immunoassay Plus ControlBio-Rad · 1998
- 1 generation backK043108 Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc. · 2004
- This deviceK092749 Mas and Mini-Trol PTH ControlMicrogenics Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K891475 | Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3 | Bio-Rad | 1989 | — |
| −2 | K981532 | Lyphochek Immunoassay Plus Control | Bio-Rad | 1998 | — |
| −1 | K043108 | Liquichek Specialty Immunoassay Control | Bio-Rad Laboratories, Inc. | 2004 | — |
| 0 (this device) | K092749 | Mas and Mini-Trol PTH Control | Microgenics Corporation | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043108 | Liquichek Specialty Immunoassay ControlSummary page 2…LLY EQUIVILANT PREDICATE DEVICE MAS® PTH Control Moni-Trol® PTH Control is substantially equivalent to the previously cleared Liquichek Tm Specialty Immunoassay Control (K043108) DESCRIPTION OF DEVICE This product is a liquid stable control material prepared from human serum. Analyte levels are adjusted w… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K043108.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent…
Read the full statement (138 words)
MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092749 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092749: Mas and Mini-Trol PTH Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092749
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026